title: Evaluation of urovysion and cytology for bladder cancer detection: a study of 1835 paired urine samples with clinical and histologic correlation.
abstract: BACKGROUND
  Urine cytology has been used for screening of bladder cancer but has been limited by its low sensitivity. UroVysion is a multiprobe fluorescence in situ hybridization (FISH) assay that detects common chromosome abnormalities in bladder cancers. For this study, the authors evaluated the effectiveness of multiprobe FISH and urine cytology in detecting urothelial cell carcinoma (UCC) in the same urine sample.
  
  
  METHODS
  In total, 1835 cases with the following criteria were selected: valid results from both the multiprobe FISH assay and urine cytology in the same urine sample, histologic and/or cystoscopic follow-up within 4 months of the original tests, or at least 3 years of clinical follow-up information. The results of FISH and cytology were correlated with clinical outcomes derived from a combination of histologic, cystoscopic, and clinical follow-up information.
  
  
  RESULTS
  Of 1835 cases, 1045 cases were from patients undergoing surveillance of recurrent UCC, and 790 were for hematuria. The overall sensitivity, specificity, positive predictive value, and negative predictive value in detecting UCC were 61.9%, 89.7%, 53.9%, and 92.4%, respectively, for FISH and 29.1%, 96.9%, 64.4%, and 87.5%, respectively, for cytology. The performance of both FISH and cytology generally was better in the surveillance population and in samples with high-grade UCC. In 95 of 296 cases with atypical cytology that were proven to have UCC, 61 cases, mostly high-grade UCC, were positive using the multiprobe FISH assay.
  
  
  CONCLUSIONS
  The UroVysion multiprobe FISH assay was more sensitive than urine cytology in detecting UCC, but it produced more false-positive results. The current data suggest that the use of FISH as a reflex test after an equivocal cytologic diagnosis may play an effective role in detecting UCC.
authors.affiliation: Department of Pathology and Laboratory Medicine, Medical University of South Carolina, Charleston, South Carolina.
authors.forename: Haythem
authors.initials: H
authors.lastname: Dimashkieh
authors.forename: Daynna J
authors.initials: DJ
authors.lastname: Wolff
authors.forename: T Michael
authors.initials: TM
authors.lastname: Smith
authors.forename: Patricia M
authors.initials: PM
authors.lastname: Houser
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Nietert
authors.forename: Jack
authors.initials: J
authors.lastname: Yang
mesh_terms: D002869:Chromosome Aberrations; D003558:Cystoscopy; D003581:Cytodiagnosis; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D017404:In Situ Hybridization, Fluorescence; D008297:Male; D060787:Neoplasm Grading; D009364:Neoplasm Recurrence, Local / Q000175:diagnosis*; D011379:Prognosis; D012189:Retrospective Studies; D012680:Sensitivity and Specificity; D001749:Urinary Bladder Neoplasms / Q000175:diagnosis*; D014556:Urine / Q000737:chemistry* / Q000166:cytology
keywords: UroVysion; bladder cancers; urine cytology; urothelial cell carcinoma